Where regulation falls down
Making Britain the safest place to take medicines is a laudable aim espoused
by the President of the Royal Pharmaceutical Society. It is a principle
worth aspiring to, but there are many difficulties in defining what
it might mean in practice. One aspect of this is analysed in the current
issue of the BMJ, as we report this week (p353). “Over the counter
medicines: proceed with caution” examines the impact of increasing
people’s access to OTC medicines and concludes that the risks
may outweigh the benefits. And these risks are in situations where
medicines availability is already heavily regulated.
Over the past few years, the Government has been encouraging pharmaceutical
companies to apply for a range of prescription medicines to be reclassified
as pharmacy medicines on the grounds that it will reduce the burden on
GPs and be easier for patients to obtain symptomatic relief of a range
of ailments. Coupled with this has been the development of minor ailment
schemes and the development of patient group directions to give specific
patient groups easier access to certain POMs. Techniques to minimise
the hazards of taking medicines include restricting the strengths of
formulations available OTC, although the downside of this is that drugs
like omeprazole or simvastatin may be less effective in OTC doses than
in doses prescribed by a GP.
The authors also explore the increasing availability of unregulated medicines
through the internet. Although the Royal Pharmaceutical Society is now
able to point patients to reliable registered internet pharmacies which
carry its logo, there will be many people who want to obtain medicines
quickly and anonymously and who are willing to take the risk of being
sent an inappropriate or worthless counterfeit medicine from abroad.
In addition, the authors point out that although pharmacists can give
clinical advice to a customer buying an OTC medicine, there will be times
when that advice is rudimentary — particularly if the pharmacy
is busy. At the same time, they acknowledge that ensuring a medicine
is only obtainable with a prescription is no guarantee that it will be
used safely.
There can never be a completely safe place to take a medicine: regulators
and health professionals can work hard to minimise the hazards to patients
who are prescribed medicines within a health service. But it is up to
the individual to decide what risks he or she is prepared to take either
by not taking a medicine, by taking more of a particular medicine than
recommended or by buying one from an unauthorised source. Educating patients
and customers about these risks is essential but no regulatory system
can control human behaviour.
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